344697BR
May 10, 2022
Romania

Job Description

110,000 professionals are working together to improve patient’s life and you can be one of them! This is your unique opportunity to become the Quality System, Compliance and Operations Manager at our department at Targu Mures. In this role you will coordinate the activities of the QSCO department within the Quality Department of the Sandoz SRL unit, ensuring the release of pharmaceutical products on the market under conditions that do not affect their quality, safety and effectiveness, as well as compliance with the rules of good manufacturing practice (GMP). You will ensure that the operation of the business is in accordance with the legal and regulatory requirements of GMP, as well as with the Novartis Corporation's Policies and Quality Manual.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Implement the local quality system that aligns with the company's standards, local regulations and all regulations in the respective countries where the products are marketed and ensure the state of preparedness for inspection and a high level of compliance
• Represent the QSCO department before health authorities and auditors; ensure appropriate communication processes are established and implemented to enable proper exchange of information with key partners; ensure adequate and timely escalation to the management of the problems related to the quality of the products and system
• Prepare activity and quality reports; coordinate the activity of the Quality Committee in accordance with the local procedure and the requirements of the Novartis Quality Manual and ensure the implementation of the actions established within this council
• Supervise activities within the Complaints Board and Change Request Board of the site; ensure that the process of batch release is carried out in good condition in accordance with the applicable local legislation and GMP rules; implement quality management programs, including the quality risk management process ensuring the identification, management and review of the identified quality problems
• Assure performance of quality trainings and staff awareness of the quality and compliance requirements and the quality management system; implement the provisions of the Novartis Quality Manual and monitor compliance from a quality point of view, including performing internal audits, evaluating quality indicators and participating in the evaluations carried out by the management and coordinate internal and external audit processes, including planning, establishment of audit teams, audit performance, drawing documentation and monitoring the implementation of corrective actions
• Safeguard the quality of all cGMP's activities from an operational point of view; participate on or coordinate the committees on the investigation of complaints, withdrawals, returns of products; perform verification of the annual product analysis for the products for which Sandoz SRL is registered as a unit responsible for the release of the batches or holder of the Marketing Authorization
• Provide integrated planning, prioritization and execution of activities through full synchronization with business requirements; ensure operation of the compartment in an efficient way and maintain an innovative approach based on improving productivity, implementing best practices and harmonizing standards and monitor and report specific performance indicators.


n/a

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• University Degree from accredited university in Chemistry or Pharmacy
• Solid knowledge of Analytical Chemistry and Pharmaceutical Industry
• Minimum 5 of years’ experience form Quality Control/ Quality Assurance/ Pharmaceutical products manufacturing from a production environment within the pharmaceutical industry.
• Solid understanding of compliance, cGMP, analytical aspects, manufacturing, storage and transportation, and regulatory aspects of pharmaceuticals
• Proficiency Level of Romanian and English (both verbal and written)

Desirable requirements:
• Familiarity with concepts and tools of lean philosophy and lean transformation projects
• Excellent communication and people leadership skills


Why consider Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges.
Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams, representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Romania
Targu-Mures
Quality
Full Time
Regular
No
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344697BR

Quality System, Compliance and Operations Manager

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